BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP

    MDR report key: 1212904 · Received October 29, 2008

    Report

    Report Number
    6000001-2007-81077
    Event Type
    Malfunction
    Date Received
    October 29, 2008
    Date of Event
    July 2, 2007
    Report Date
    July 2, 2007
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    PMA / PMN Number
    K010566
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING RESUBMITTED IN ACCORDANCE WITH INSTRUCTIONS FROM THE FDA TO ADDRESS A MANUFACTURER REPORT SEQUENCE NUMBER ISSUE THAT OCCURRED WHEN THIS MDR OR SUPPLEMENT WAS ORIGINALLY SUBMITTED TO THE FDA AUGUST 1, 2007. EVALUATION SUMMARY: THE CUSTOMER REPORTED CONDITION OF KEEPS GETTING AIR IN LINE ALARM IS CONFIRMED ON CHANNEL C. THE ALARM IS CONSTANT AT START-UP. THE ALARM IS CAUSED BY A DEFECTIVE AIR IN LINE PRINTED CICUIT BOARD (AIL PCB) ON CHANNEL C. THE CHANNEL C, AIL PCB WAS REPLACED.

    Description of Event or Problem · 1

    THE FACILITY REPORTED TO LARGO CUSTOMER SERVICE A PUMP THAT KEEPS GETTING THE AIR IN LINE ALARM. IT IS UNKNOWN WHEN THIS CONDITION OCCURRED. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION NECESSARY ACCORDING TO THE HOSPITAL REPRESENTATIVE. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP 80FRN FRN BAXTER HEALTHCARE PTE. LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1